A comparative study on the adverse reactions of purified chick embryo cell vaccine (PCEC) and purified vero cell rabies vaccine (VERO) administered intramuscular as post exposure prophylaxis
This study is a double blind, randomized, clinical trial. The aims of this study is assessment of adverse local and systemic reactions of two approved rabies vaccine; purified chick embryo cell vaccine (PCEC) and purified vero cell rabies vaccine (VERO). Study populations include people bitten by animals from 8 different cities of Iran (Ghaemshahr, Sari, Gonbad, Aqqala, Gorgan, Kerman, Sirjan and Bam).
Individuals will include in the study, if they are between 5 and 55 years of age and volunteer to participate in the study. They will exclude from the study if they have a history of previous animal bites; have received immunization against rabies previously; have a significant acute or chronic infectious disease; receiving transfusion with blood or blood products within the past month; are concomitantly receiving corticosteroids or immunosuppressive drug therapy; have axillary temperature 37.5°C before injection; or in the case of females, are pregnant. The study will started simultaneously at all healthcare centers and will be conducted for a period of one year from 2011 to 2012.
Randomization will performed using the balanced block randomization; for 1:1 randomization of 2 groups and the blocks size of 4. Immediate systemic and local adverse reaction to the vaccines will monitored by the noninjecting physician within 30 minutes after each injection. Local and systemic reactions also, will be evaluated daily for 3 days after each injection by patients; and will be recorded on a special form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102124470N1
Registration date:2015-11-13, 1394/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Azra Ramezankhani
Name of organization / entity
Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Science, Shahid
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
az.ramezankhani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Center of Disease Control (CDC), Ministry of Health, Tehran, Iran
Expected recruitment start date
2011-12-01, 1390/09/10
Expected recruitment end date
2012-12-01, 1391/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the adverse reactions of purified chick embryo cell vaccine (PCEC) and purified vero cell rabies vaccine (VERO) administered intramuscular as post exposure prophylaxis
Public title
Comparison of adverse reactions of two rabies vaccine
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age between 5 and 55 years; volunteer to participate in the study.
exclusion criteria: have a history of previous animal bites; receiving immunization against rabies previously; have a significant acute or chronic infectious disease; receiving transfusion with blood or blood products within the past month; concomitantly receiving corticosteroids or immunosuppressive drug therapy; have axillary temperature 37.5°C before injection; being pregnant in females
Age
From 5 years old to 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
1800
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The committee of rabies control, Ministry of Health and Medical Education, Tehran, I. R. of Iran.
In intervention group PCEC will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccination against rabies serum) according to the World Health Organization's classification.
Category
Treatment - Drugs
2
Description
In control group Vero will be administered with 5 doses on days 0, 3, 7, 14, and 28, in animal bite subjects, who are classified in the second group (emergency vaccination) and third (routine vaccination against rabies serum) according to the World Health Organization's classification.